JOURNAL ONKOLOGIE – STUDIE
Comparison Between Endovascular and Bronchoscopic Tumor Marker Insertion for Real-time Stereotactic-guided Radiotherapy in Lung Cancer
Rekrutierend
NCT-Nummer:
NCT04684186
Studienbeginn:
Oktober 2016
Letztes Update:
12.01.2021
Wirkstoff:
-
Indikation (Clinical Trials):
Lung Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborator:
-
Kontakt
Kontakt:
Phone: +41213144444
E-Mail: rafael.duran@chuv.ch» Kontaktdaten anzeigen
Studienlocations
(1 von 1)
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Rafael DURAN
Phone: +41213144444
E-Mail: rafael.duran@chuv.ch» Ansprechpartner anzeigen
Studien-Informationen
Brief Summary:The role of radiotherapy is well established in the management of early stage lung cancer or
as part of a multidisciplinary approach of locally advanced lung cancer (1).
Recent advances in Cyberknife© technology, which is a robotic system of stereotactic
irradiation including localisation and real time lesion-tracking, has led to an increase in
accuracy and potentially in efficiency of the irradiation of tumor field (2)(3). According to
several studies, promising results in local control and survival rates have been achieved in
patients suffering from primary lung cancer or peripheral lung metastasis treated with
Cyberknife© (4)(5)(6)(7)(8).
Fiducial markers are implanted in or near a tumor in a configuration defining a COM (center
of mass) guiding the Cyberknife for tumor localization.
Tumor movement is then synchronized to respiratory cycle motion during treatment which
reduces toxicity of non target lung tissue irradiation. Change in marker positioning leads to
COM alterations, thus limiting detection by the tracking system.
Percutaneous (9)(10)(11) (12), endovascular (12)(13) fiducial implantation or by means of
bronchoscopic devices (14)(15)(16)(17)(18) are three techniques that have been validated in
previous studies as feasible and safe procedures, providing accurate tracking.
Few studies are currently available in the litterature comparing these modalities (19)(20).
The percutaneous implantation technique will not be considered for this study because this
technique is associated with a high risk of pneumothorax (9).
Both the endobronchial and endovascular technique have been described in the literature with
equivalent success rate (87-90%) in intention to treat (21)(22).
One of the endpoints of this study is to verify that these results are reproducible in our
institution where both techniques are currently available and to investigate other secondary
endpoints such as fiducial marker migration after placement, complications rates and
procedure time.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Lung cancer (primary or secondary, any histological type)
- Early stage lung cancer: patients diagnosed with stage I for which operation is
contra-indicated, for example because of cardiac or pulmonary comorbidities.
- Locally advanced lung cancer stages II - IIIB
- Metastatic lung cancer stage IV (palliative care)
- 18 y ≤ age ≤ 85 y
Exclusion Criteria:
- age <18y
- incapacity of judgment
- Absence of a signed consent form
Studien-Rationale
Primary outcome:1. Cyberknife© tracking (Time Frame - Before Cyberknife):
Tumor tracking assessment by Cyberknife© after bronchoscopic and endovascular fiducial marker implantation
Secondary outcome:
1. Fiducial implantation evaluation by operator (Time Frame - Immediately post-implantation):
Assessment of technical feasibility of implantation of at least three fiducial markers around the lung tumor in both techniques
2. Fiducial marker migration (Time Frame - Immediately post-implantation and before Cyberknife):
Secondary fiducial migration rate assessment in both techniques
3. Procedure time (Time Frame - Immediately after the procedure):
Procedure time required for the implantation of three markers around the lung tumor in both techniques
4. Complication rate (Time Frame - within 30 days of fiducial marker placement):
Complication rate (AE/SEA) within 30 days of fiducial marker placement in both techniques
Studien-Arme
- Endovascular fiducial marker insertion
Fiducial markers are inserted and released near the tumor through femoral puncture. A catheter is led through the venous system to the right heart and from there through the heart into the pulmonary arteries. - Bronchoscopic fiducial marker insertion
Fiducial markers are inserted and released near the tumor into the bronchi using an endoscopic route
Geprüfte Regime
- Endovascular fiducial marker insertion:
Fiducial markers will be inserted using an endovascular route - Bronchoscopic fiducial marker insertion:
Fiducial markers will be inserted using an endoscopic route
Quelle: ClinicalTrials.gov
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